Effectiveness and Tolerability of Fitostimoline Plus vs Connettivina Bio Plus in Skin Graft (FP)

Clinical Evalutation of the Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze in the Treatment of Skin Graft Controlled Randomized Pilot Study

Partial thickness skin grafts are widely used to cover large losses of substance secondary to trauma, burns, ulcers, neoplasms.

The donor site (SD), in principle, heals by spontaneous re-epithelialization from the epithelial residues of the skin appendages.

In the post-surgical management of the collection area, in order to optimize treatment, the following are necessary: control of nappy bleeding, management of transudate, avoid superinfection, promote rapid re-epithelialization and pain control.

The objective of the research proposed by us wants to compare two methods of dressing of the SD, one of which involves the use of impregnated gauze and cream with Rigenase and poliesanide (Fitostimoline Plus®) while the other the use of impregnated gauze and cream with hyaluronic acid, sodium salt and 1% silver sulfadiazine (Connettivina Bio Plus®) associated with non-adhesive polyurethane foam (i.e. without adhesive edge, i.e. Mepilex).

The prospective, multicentre study will be conducted at the UOC of Plastic and Reconstructive Surgery of our AOU directed by Prof F. D'Andrea and the UOC of Plastic and Reconstructive Surgery of ASUGI of Trieste directed by Prof Z. Arnez.

To date, there is still no standardized protocol on the wound care of the graft harvesting area. If the literature is evaluated, in fact, large variations in the management of SD are observed with a discrepancy between the practice and the evidence reported in the literature.

The purpose of our research is precisely to review the literature on the effectiveness of dressings at the sampling site level in terms of reducing pain and promoting rapid healing.

Study Overview

• Status: Recruiting
• Conditions: Wounds and Injuries; Skin Graft Scar; Skin Graft Complications
• Intervention / Treatment: Device: Fitostimoline plus; Device: Connettivina bio plus

Detailed Description

The management of the removal site of a partial thickness graft is still a subject of heated debate where, despite the published works, it is still often treated with empirical methods, sometimes which also differ within the same working group. The treatment of AD usually, despite what has been exposed in numerous scientific papers, only involves the use of greasy gauze impregnated with substances that promote re-epithelialization or simple paraffin gauze.

The aim of our research is to compare the effectiveness of bioactive dressings containing Rigenase in association with polyhexanide (PHMB) - Fitostimoline Plus®- with bioactive dressings with hyaluronic acid and Silver sulfadiazine - Connettivina Bio Plus®- in improving the outcome of patients, evaluating:

• cure rate
• the healing times
• the AD infection rate
• pain control / discomfort
• assessment of the scar

RESEARCH OBJECTIVES AND HYPOTHESIS The objective of the study proposed by us is to compare two methods of treating DS; the first involves the use of impregnated gauze and cream containing Rigenase® + polyhexanide; the second is the use of impregnated gauze and sodium salt hyaluronic acid cream. The secondary dressing is a non-adhesive polyurethane foam in both groups.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: barbara NA maglione, MB; Phone Number: 3343293357; Email: barbara.maglione@farmadamor.it

Study Locations

• Italy
  • Naples
    • Napoli, Naples, Italy, 80123
      • Recruiting
      • Barbara Maglione
      • Contact: barbara maglione; Phone Number: 3343293357

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All pantients aged between 18 and 80 years will be included in the trial if they accept to sign the informed consent.

Description

Inclusion Criteria:

• informed consent Age > 18 years

Exclusion Criteria:

• Absence of informed consent Age < 18 years

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fitostimoline Plus; Formulation in gauzes and cream based on a particular Triticum Vulgare Extract (Rigenase®) and polyhexanide, an antiseptic which does not give any bacterial resistance.	Device: Fitostimoline plus; Formulation in gauzes and cream; Device: Connettivina bio plus; Formulation in gauzes and cream
Connettivina Bio Plus; Formulation in gauzes and cream based on hyaluronic acid and silver sulphadiazine.	Device: Fitostimoline plus; Formulation in gauzes and cream; Device: Connettivina bio plus; Formulation in gauzes and cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scarring	Comparing the two formulations in evaluating the scarring percentage of the lesions	one month

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): December 18, 2021
• Study Completion (Anticipated): September 18, 2022

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 1808

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No